Hello all, The manufacturer of the end-use product must ALSO submit an application to the CDRH (as a LASER PRODUCT) when they are incorporating an existing OEM laser or laser system that has a CDRH accession # associated with it. This manufacturer will then get a different accession # on this new submittal & must also do an annual report submission.
You can obtain a guidance document directly from the CDRH at: https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments One of the definitions that are basic to the regulations are: A LASER PRODUCT is any device that constitutes, incorporates, or is intended to incorporate a laser or laser system [CFR 1040.10 (b) (21)] The accession # that is given to the manufacturer of the LASER PRODUCT system is merely just a tracking # (not a CDRH approval) for the end product model it is being sold into the USA. Hope that helps. Regan Arndt On Tue, Jun 18, 2024 at 2:47 PM Jim Bacher, WB8VSU <j.bac...@ieee.org> wrote: > Steve, both. The client has to file a yearly report as well. The client > just refers to the OEMs FDA Accession number along with detailing labeling, > manuals, etc. > > > Jim Bacher, WB8VSU > j.bac...@ieee.org or ja.bac...@outlook.com > JBRC Consulting LLC > Product EMC & Regulatory Consultant > https://trc.guru/ email:j...@trc.guru > IEEE Life Senior Member > > > On June 18, 2024 5:39:08 PM sgbrody <sgbr...@comcast.net> wrote: > >> I have a client with a product that has a 3rd party Class 3B laser >> embedded. >> >> Who needs an FDA Accession number - laser manufacturer or my client as an >> end product containing an embedded laser? >> >> Thanks, >> >> > ------------------------------ > > This message is from the IEEE Product Safety Engineering Society emc-pstc > discussion list. To post a message to the list, send your e-mail to > EMC-PSTC@LISTSERV.IEEE.ORG > All emc-pstc postings are archived and searchable on the web at: > https://www.mail-archive.com/emc-pstc@listserv.ieee.org/ > > Website: https://ewh.ieee.org/soc/pses/ > Instructions: https://ewh.ieee.org/soc/pses/list.html (including how to > unsubscribe) <https://ewh.ieee.org/soc/pses/list.html> > List rules: https://ewh.ieee.org/soc/pses/listrules.html > > For help, send mail to the list administrators: > Mike Sherman at: msherma...@comcast.net > Rick Linford at: linf...@ieee.org > > For policy questions, send mail to: > Jim Bacher at: j.bac...@ieee.org > ------------------------------ > > To unsubscribe from the EMC-PSTC list, click the following link: > https://listserv.ieee.org/cgi-bin/wa?SUBED1=EMC-PSTC&A=1 > - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to EMC-PSTC@LISTSERV.IEEE.ORG All emc-pstc postings are archived and searchable on the web at: https://www.mail-archive.com/emc-pstc@listserv.ieee.org/ Website: https://ewh.ieee.org/soc/pses/ Instructions: https://ewh.ieee.org/soc/pses/list.html (including how to unsubscribe) List rules: https://ewh.ieee.org/soc/pses/listrules.html For help, send mail to the list administrators: Mike Sherman at: msherma...@comcast.net Rick Linford at: linf...@ieee.org For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> _________________________________________________ To unsubscribe from the EMC-PSTC list, click the following link: https://listserv.ieee.org/cgi-bin/wa?SUBED1=EMC-PSTC&A=1
